CMS tightens rules on 54 organ groups as 100,000 wait

More than 100,000 Americans are waiting for an organ transplant, the Centers for Medicare & Medicaid Services said Oct. 30 as it finalized a rule that tightens oversight of the groups that recover donated organs.

Those groups are organ procurement organizations, or OPOs. There are 54 of them, serving 55 donation service areas, according to the final rule. Each one works with hospitals to get consent from donor families, recover organs and get them to transplant teams.

More than 49,000 transplants were performed in the U.S. in 2025, CMS said. Another person is added to the waiting list every 8 minutes, the rule says.

What changes

The rule defines “unsound medical practices” for the first time. CMS describes them as failures that create an imminent threat to patient health and safety, including failures in donor evaluation, procurement, allocation and transport, according to a CMS fact sheet. That gives the agency a clear basis to decertify an OPO immediately.

The other changes:

• OPOs must keep records of what happens to every organ sent for research.
• A pancreas recovered only for islet cell research no longer counts as a transplant in an OPO’s score. The donor still counts toward its donation rate.
• An OPO’s medical director must hold a license in at least one state or territory the OPO serves.
• When one OPO takes over another’s area, the outgoing group must cooperate. The incoming group must file a transition plan and send CMS progress reports.
• The appeals process is written into the rule, including a discretionary review by the CMS Administrator.

CMS said the pancreas change makes sure transplant scores reflect organs that went into patients.

The scorecard stays

The rule keeps the tier system set by a December 2020 rule. Every OPO is graded on two numbers: its donation rate and its transplant rate.

OPOs in tier 1 are recertified for four more years. Tier 2 OPOs can be recertified but must compete to keep their areas. OPOs with only tier 3 areas are decertified and cannot compete for any other area.

The current recertification cycle runs from 2022 through 2026. CMS said it “will be moving to decertify tier 3 OPOs as indicated in the 2020 final rule.”

Since that 2020 rule, organ donations have risen 36% nationwide and transplants have risen 30%, CMS said.

Cost and timing

CMS estimates the rule will cost about $16.5 million in its first year and $7.9 million a year after that. It counts about $598,000 a year in benefits from fewer compliance questions.

The rule is scheduled to publish in the Federal Register on Nov. 3. It takes effect 60 days after publication. CMS received 129 comments on the proposal it released in January.

HHS Secretary Robert F. Kennedy Jr. said the agency is “holding failing organizations accountable.” CMS Administrator Dr. Mehmet Oz said the rule promotes “swifter consequences for bad actors.”

Why it matters

An OPO handles every step from a donor family’s consent to an organ’s arrival at a transplant team. Until now, CMS had no written definition of practices bad enough to close one on the spot. It has one now, and the 2022 to 2026 cycle ends this year with tier 3 groups set to lose their areas. For the 100,000 people on the list, CMS can now replace or shut down a failing group in their region faster.